NOXXON Pharma N.V a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today the completion of patient recruitment in its Phase 1/2 brain cancer study with lead candidate, NOX-A12 plus radiotherapy.
All three patients participating in the third and final dose cohort have been successfully enrolled and received initial treatment. NOXXON’s Phase 1/2 clinical study is investigating three-dose regimens of CXCL12 inhibitor, NOX-A12 (200, 400, and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed brain cancer patients.
Once the last patient in the third cohort completes four weeks of therapy with NOX-A12 combined with radiotherapy, the independent Data Safety Monitoring Board (DSMB) will convene to assess the safety and tolerability of 600 mg NOX-A12 per week, the highest dose planned in the study. As outlined in the approved study protocol, it is planned for each patient to be treated with NOX-A12 for up to six months. Top-line data from this arm is planned to be available in November 2021.
“The combination of NOX-A12 and radiotherapy has been well tolerated by the participating patients so far. In the upcoming and final planned DSMB meeting, the safety of the highest dose tested will be assessed. Once patients have received treatment over a longer time period, the clinical investigators will analyze all available trial data to define the recommended dose for a Phase 2 glioblastoma study,” said Prof. Frank Giordano, Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn.
“Completing patient recruitment for this dose-escalation study is an important step in the continued clinical assessment of our novel therapy for patients with difficult-to-treat and highly aggressive brain cancer. We are currently preparing the submission of a protocol amendment to allow the inclusion of additional patients with the goal of expanding the database for the recommended Phase 2 dose. In addition, our expansion aims to create a basis for enrolling a broader group of patients in future studies, in particular brain cancer patients who would also receive chemotherapy in addition to NOX-A12. Notably, this would allow NOX-A12 to be tested in all first-line glioblastoma patients,” commented Aram Mangasarian, CEO of NOXXON.